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Generic Lipitor Recalled - Another Sign The FDA Needs Help?

WASHINGTON, DC - NOVEMBER 15: Commissioner of Food and Drug Administration Peggy Hamburg testifies during a hearing before the Senate Health, Education, Labor and Pensions Committee November 15, 2012 on Capitol Hill in Washington, DC. The hearing was focused on the meningitis outbreak originating at a Massachusetts pharmacy that has killed 32 people and sickened 461 more. (Image credit: Getty Images via @daylife)

Ingesting glass does not lower your cholesterol, but patients taking Ranbaxy’s generic version of Pfizer‘s blockbuster cholesterol-lowering drug Lipitor might be doing just that. Ranbaxy announced today that it was recalling a large number of batches of its generic Lipitor as they might include very small glass particles – something that could be dangerous if ingested.

Generics from other manufacturers have not been recalled. The recall is a small positive for Pfizer, which makes branded Lipitor. Pfizer has a generic drug division named Greenstone and some consumers might feel most comfortable asking for the Greenstone generic Lipitor.

The Ranbaxy recall comes after a host of problems with Ranbaxy in recent years – including recalls, admissions of false testing data presented to the FDA, and other manufacturing problems. The troubles at Ranbaxy also point to the challenge a foreign drug company has when buying another drug company. Almost immediately after Daiichi Sankyo acquired a majority stake in Ranbaxy, problems sprang up. With no expertise running an Indian generics drug company, let alone one that had been family controlled up to that point, DaiichiSankyo was blindsided by the troubles.

Ranbaxy shares dropped only 3% on this news today, but both Ranbaxy and Daiichi Sankyo shares have fallen since the two have paired up. Daiichi Sanko acquired a nearly 70% stake in Ranbaxy for approximately $4.8 billion according to Sankyo materials in 2008, with an initial price of approximately Rs 737 per share. Ranbaxy’s stock is now trading at Rs 496.

Daiichi Sankyo stock was approximately ¥3000 when the deal for Ranbaxy was announced, and now stands at ¥1267. While a market fall and global recession have happened in the intervening years, it is safe to say that Ranbaxy has not turned out nearly as well as Daiichi Sankyo had hoped.

Is The FDA Just “A Little Too Little, A Little Too Late”

This recall of the US’s most prescribed drug comes at a bad time for the FDA – now dealing with the fallout from the meningitis outbreak from a compound pharmacy and just a short time after the FDA recalled another high profile drug – the generic version of the blockbuster anti-depressant Wellbutrin XL after it was found not to work like the brand drug. Additionally, in recent years the FDA has been criticized for being too lenient with manufacturers, such as with the negotiated J&J phantom recall two years ago. While some might argue it is good that the FDA caught this problem and that is the sign things are working, others might criticize the FDA for approving Ranbaxy’s generic Lipitor while knowing how poor Ranbaxy’s history has been. Was the FDA being pressured by industry, payors and generic drug companies, to get an approval out given how large Lipitor was to public health spending? We don’t know. But what we do know is that each time the FDA has a high profile recall like generic Lipitor or Wellbutrin XL, scrutiny of future approvals increases. While the FDA’s catching a problem is good, more scrutiny is needed to determine why such problems occurred in the first place. Whether this recall will impact already-delayed timelines is another unknown, but it seems like that is a logical conclusion for a monitoring system that seems to be succeeding at catching problems, but not until the products are in consumer hands and bodies.

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So I called CVS who said, “Don’t worry, your strength of the generic Lipitor was not recalled.” I said, “Ranbaxy put glass in a drug and you say don’t worry???” CVS said, “Sorry.” I said goodbye…..taking my business to a drug store that cares.

So I just called CVS too and was asked the date I filled the prescription. I told them 10/21/2012 and the pharmacist said no don’t worry. I asked why I shouldn’t worry and he said they’d known about it for a long time and the FDA knew about it for a long time, and anything after September was OK. I told him but I didn’t know about it until it hit the papers and hour ago and he said well yes but they knew. So it seems like someone’s been sitting on this information for a while. Guess us Muppets are the last to know.

Well it is. I’m basically sitting here with a few pills (40 mg) left in a bottle with the name Ranbaxy on it and I guess I’m supposed to just forget about it and swallow. One question I have is can the FDA rely on Ranbaxy’s information that it was only those batches are affected, or have they actually developed their own information. Even if they could, FDA can’t do recalls anyway, can they? They’ve got to rely on the good intentions of folks like Ranbaxy. Scary.

I have been taking Zocor (simvastatin) since 2001. I never had a problem when I was switched to the generic by the Veterans Administration four years ago. Suddenly the VA switched to another generic supplier for simvastatin. The size, shape, and color changed. Within three days of changing to the new generic, I started suffering pain in all my muscles. I told the VA doctor I though it was due to the new supplier having something wrong with their medicine. Instead of investigating that, the VA doctor switched me to Pravastatin. I still think the new simvastatin being given out by the VA had something wrong with it.

I take the generic form of LIPITOR. How do I find out if it’s one of the batches that was found to have slivers of glass in it? I purchase my LIPITOR via Walmart in Georgia. Please advise ASAP if you know the answer.

I love red meated grapefruit and I eat over 100 per year and have done so for many (over 20) years. I am 70 years old and my LDL is “optimum” range. My family has had LDL problems for years–I do not. I do not take any LDL lowering drugs. By the way, I have two large red meated grapefruit trees that make a huge crop every year.